FDA Opens Pocketbook for Children

FDA has awarded a $1 million grant to the MISTRAL Collaborative in conjunction with the Institute for Pediatric Innovation to commercialize innovative medical devices for the pediatric population. The MISTRAL (Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory) Collaborative is a joint effort by SRI International and the Stanford University School of Medicine.

The groups say that one of the primary goals is to identify new device opportunities for the newborn intensive care unit. The grant will also fund the development of surgical tools and catheter-related products.

"Children are the 'orphans' of the medical device industry," says Sanjeev Dutta, MD, associate professor of surgery and of pediatrics at the Stanford University School of Medicine. "Market and regulatory concerns often prevent medical device companies from investing in pediatric-specific device development. Not infrequently, appropriate devices that specifically address pediatric diseases are simply not available, leaving some practitioners to use adult devices on kids or 'jerry-rig' their own solutions. The MISTRAL Collaborative, with this tremendous boost from the FDA, hopes to catalyze pediatric device development by performing the initial R&D, partnering with industry, and identifying paths to market for badly needed pediatric devices."